Promoting Asylum-seeking and Refugee Children's Coping With Trauma
Primary Purpose
Mental Health Disorder, Post-Traumatic Stress Disorder in Adolescence, Depression
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Teaching Recovery Techniques, TRT
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Disorder focused on measuring Teaching Recovery Techniques, Asylum-seeking children, Refugee children, Low-threshold intervention
Eligibility Criteria
Inclusion Criteria:
- Accompanied asylum-seeking children living in reception centers,
- Unaccompanied asylum-seeking children living in reception centers
- Unaccompanied refugee minors who have been granted residence
Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items
-
Exclusion Criteria:
- Psychosis,
- Mental disabilities
Sites / Locations
- Bergen Municipality
- Nordre Land municipality
- Drammen Municipality
- Engerdal Municipality
- Fredrikstad municipality
- Gjøvik municipality
- Ringerike Municipality
- Grue municipality
- Levanger municipality
- Lyngdal municipality
- Lyngdal municipality
- Bærum municipality
- Salten municipality
- Stavanger municipality
- Trondheim municipality
- Vadsø municipality
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Wait-list control group
Arm Description
Teaching Recovery Techniques implemented 1- 3 weeks after recruitment
Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)
Outcomes
Primary Outcome Measures
Children's Revised Impact of Event Scale (CRIES-13)
Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)
Secondary Outcome Measures
Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
Measures if children have perceived each anxiety symptom over the last three months from "not true, or hardly ever true" (0), "somewhat true or sometimes true" (1) "very true or often true" (2)
Cantril Ladder
Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)
Montgomery-Aasberg Depression Scale, MADRS
9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).
Full Information
NCT ID
NCT03822598
First Posted
January 21, 2019
Last Updated
January 28, 2019
Sponsor
Norwegian Institute of Public Health
Collaborators
University of Tromso, University of Bergen, Norwegian Directorate of Children, Youth, and Family Affairs, Norwegian Directorate of Immigration, Norwegian Directorate of Integration and Diversity
1. Study Identification
Unique Protocol Identification Number
NCT03822598
Brief Title
Promoting Asylum-seeking and Refugee Children's Coping With Trauma
Official Title
Implementation and Evaluation of Teaching Recovery Techniques (TRT) Among Asylum-seeking and Refugee Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian Institute of Public Health
Collaborators
University of Tromso, University of Bergen, Norwegian Directorate of Children, Youth, and Family Affairs, Norwegian Directorate of Immigration, Norwegian Directorate of Integration and Diversity
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children.
The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.
Detailed Description
Teaching Recovery Techniques (TRT) was developed by Children and War Foundation (www.childrenandwarfoundation.org ) as a tool to support children in coping with their mental reactions to being exposed to war and catastrophes. TRT has proven to be effective in reducing trauma-related mental health symptoms in such contexts. However, it has never been used with children experiencing all the uncertainties and stress of an asylum-seeking context, or with refugee children in high-income countries. The main aim of the present study is therefore to implement and evaluate the TRT among asylum-seeking and refugee children in the context of four different care conditions: 1)asylum-seeking children who arrived accompanied by a legal care-taker 2) asylum-seeking children less than 15 years in care centers administered by the Child Welfare Services 3) asylum-seeking children 15 years and older living in asylum centers regulated by the Directorate of Immigration 4) Former unaccompanied asylum-seeking children who have been granted residence (refugees) and are resettled in a municipality in Norway.
Based on Power analyses, the target group is 40 children in each care condition (total n = 160) > 9 years speaking Arabic, Tigrinya, Somali, Dari, or Pashto.
The study employs a randomized clustered experimental design that includes a waiting list control group, which will receive the TRT when the intervention group has completed the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Post-Traumatic Stress Disorder in Adolescence, Depression, Social Anxiety
Keywords
Teaching Recovery Techniques, Asylum-seeking children, Refugee children, Low-threshold intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Two stages of recruitment: 1) We recruited asylum reception centers and refugee resettlement municipalities located all over Norway 2) Invite asylum-seeking and refugee children in these institutions to participate, and assigning them by intstitution to control and intervention conditions. The intervention groups started implementing TRT between late September and late October. The control groups started implementing TRT between medio November and beginning of February.
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Teaching Recovery Techniques implemented 1- 3 weeks after recruitment
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
Delayed implementation of Teaching Recovery Techniques (after the experimental group has completed the program)
Intervention Type
Behavioral
Intervention Name(s)
Teaching Recovery Techniques, TRT
Intervention Description
TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy
Primary Outcome Measure Information:
Title
Children's Revised Impact of Event Scale (CRIES-13)
Description
Self-reported symptoms of intrusion, hyperarousal and avoidance. ' The participants check how often during the last week they had each symptom from "never" (0); "rarely" (1) "sometimes" (3) and "frequently" (5)
Time Frame
Change in CRIES-13 scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Secondary Outcome Measure Information:
Title
Screen for Child Anxiety Related Disorders (SCARED). 9 items tapping symptoms of generalized anxiety disorder, and 7 items tapping symptoms of social anxiety
Description
Measures if children have perceived each anxiety symptom over the last three months from "not true, or hardly ever true" (0), "somewhat true or sometimes true" (1) "very true or often true" (2)
Time Frame
Change in SCARED-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Title
Cantril Ladder
Description
Measures current subjective well-being on a ladder With 11 steps from "worst possible life" (0) to "best possible life" (10)
Time Frame
Change in scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
Title
Montgomery-Aasberg Depression Scale, MADRS
Description
9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life over the last three days. Each item is scored between 0 (not a problem for me) and 3 (affects me very much), with three intermediate levels (0.5, 1.5, 2.5).
Time Frame
Change in MADRS-scores from baseline (T1) to two weeks (T2) and two months after intervention is completed.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Accompanied asylum-seeking children living in reception centers,
Unaccompanied asylum-seeking children living in reception centers
Unaccompanied refugee minors who have been granted residence
Children in the target Groups reported symptoms of post-traumatic stress above clinical cut-off on Children's Revised Impact of Event Scale, 8 items
-
Exclusion Criteria:
Psychosis,
Mental disabilities
Facility Information:
Facility Name
Bergen Municipality
City
Bergen
Country
Norway
Facility Name
Nordre Land municipality
City
Dokka
Country
Norway
Facility Name
Drammen Municipality
City
Drammen
Country
Norway
Facility Name
Engerdal Municipality
City
Drevsjø
Country
Norway
Facility Name
Fredrikstad municipality
City
Fredrikstad
Country
Norway
Facility Name
Gjøvik municipality
City
Gjøvik
Country
Norway
Facility Name
Ringerike Municipality
City
Hønefoss
Country
Norway
Facility Name
Grue municipality
City
Kirkenær
Country
Norway
Facility Name
Levanger municipality
City
Leira
Country
Norway
Facility Name
Lyngdal municipality
City
Lyngdal
Country
Norway
Facility Name
Lyngdal municipality
City
Lyng
Country
Norway
Facility Name
Bærum municipality
City
Rud
Country
Norway
Facility Name
Salten municipality
City
Sjøvegan
Country
Norway
Facility Name
Stavanger municipality
City
Stavanger
Country
Norway
Facility Name
Trondheim municipality
City
Trondheim
Country
Norway
Facility Name
Vadsø municipality
City
Vadsø
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not yet known if there will be a plan to make Individual Patient Data (IPD) available. If IPD are to be shared, we follow the regulations of the Norwegian Institute of Public Health
Learn more about this trial
Promoting Asylum-seeking and Refugee Children's Coping With Trauma
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